• Camilla Dalby Hansen, Eva-Marie Gram-Kampmann, Johanne Kragh Hansen, Mie Balle Hugger, Bjørn Stæhr Madsen, Jane Møller Jensen, Sara Olesen, Nikolaj Torp, Ditlev Nytoft Rasmussen, Maria Kjærgaard, Stine Johansen, Katrine Prier Lindvig, Peter Andersen, Katrine Holtz Thorhauge, Jan Christian Brønd, Pernille Hermann, Henning Beck-Nielsen, Sönke Detlefsen, Torben Hansen, Kurt Højlund, Maja Sofie Thiele, Mads Israelsen, and Aleksander Krag.
• Department of Gastroenterology and Hepatology, Odense University Hospital, and Institute of Clinical Research, University of Southern Denmark, Odense, Denmark (C.D.H., M.B.H., N.T., M.K., S.J., K.H.T., M.S.T.).
• Ann. Intern. Med. 2023 Jan 1; 176 (1): 102110-21.

BackgroundIt remains unclear if a low-carbohydrate, high-fat (LCHF) diet is a possible treatment strategy for type 2 diabetes mellitus (T2DM), and the effect on nonalcoholic fatty liver disease (NAFLD) has not been investigated.ObjectiveTo investigate the effect of a calorie-unrestricted LCHF diet, with no intention of weight loss, on T2DM and NAFLD compared with a high-carbohydrate, low-fat (HCLF) diet.Design6-month randomized controlled trial with a 3-month follow-up. (ClinicalTrials.gov: NCT03068078).SettingOdense University Hospital in Denmark from November 2016 until June 2020.Participants165 participants with T2DM.InterventionTwo calorie-unrestricted diets: LCHF diet with 50 to 60 energy percent (E%) fat, less than 20E% carbohydrates, and 25E% to 30E% proteins and HCLF diet with 50E% to 60E% carbohydrates, 20E% to 30E% fats, and 20E% to 25E% proteins.MeasurementsGlycemic control, serum lipid levels, metabolic markers, and liver biopsies to assess NAFLD.ResultsThe mean age was 56 years (SD, 10), and 58% were women. Compared with the HCLF diet, participants on the LCHF diet had greater improvements in hemoglobin A1c (mean difference in change, -6.1 mmol/mol [95% CI, -9.2 to -3.0 mmol/mol] or -0.59% [CI, -0.87% to -0.30%]) and lost more weight (mean difference in change, -3.8 kg [CI, -6.2 to -1.4 kg]). Both groups had higher high-density lipoprotein cholesterol and lower triglycerides at 6 months. Changes in low-density lipoprotein cholesterol were less favorable in the LCHF diet group than in the HCLF diet group (mean difference in change, 0.37 mmol/L [CI, 0.17 to 0.58 mmol/L] or 14.3 mg/dL [CI, 6.6 to 22.4 mg/dL]). No statistically significant between-group changes were detected in the assessment of NAFLD. Changes were not sustained at the 9-month follow-up.LimitationOpen-label trial, self-reported adherence, unintended weight loss, and lack of adjustment for multiple comparisons.ConclusionPersons with T2DM on a 6-month, calorie-unrestricted, LCHF diet had greater clinically meaningful improvements in glycemic control and weight compared with those on an HCLF diet, but the changes were not sustained 3 months after intervention.Primary Funding SourceNovo Nordisk Foundation.

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